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Press Release

Real-world data for OTEZLA® (apremilast) demonstrates benefits beyond skin improvement for patients with chronic plaque psoriasis

Posted on: 30 Nov 17

Analysis of interim data from APPRECIATE is consistent with the efficacy and safety results from the ESTEEM clinical trials in patients with moderate to severe plaque psoriasis

Findings indicate OTEZLA® may address the diverse needs identified as important by patients, including skin improvement, being itch free, the ability to live a normal life and less time for daily treatments


Boudry, Switzerland – Boudry, Switzerland – [30 November 2017] – Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), will announce the interim analysis from the Apremilast Clinical Treatment Experience in Psoriasis (APPRECIATE) study for OTEZLA® (apremilast), an oral phosphodiesterase 4 (PDE4) inhibitor, at the 8th International Congress on Psoriasis: From Gene To Clinic in London.

This is an interim analysis from the multinational, retrospective, cross-sectional study which will include more than 450 psoriasis patients across 100 treatment sites in six countries. APPRECIATE aims to understand the treatment goals that patients and physicians hope to achieve, and describe the effectiveness of OTEZLA® beyond regulatory endpoints.

Dr Elise Kleyn, Clinical Senior Lecturer and Consultant Dermatologist, The Dermatology Centre, The University of Manchester said: “Psoriasis is a complex, heterogeneous, chronic condition and the impact on patients goes well beyond the extent of skin involvement. While also assessing the therapeutic benefits of OTEZLA® in a real-world setting, the APPRECIATE study aims to identify the treatment needs and outcomes most important to patients living with moderate to severe plaque psoriasis as well as highlight how individualised these can be.”

This interim analysis of the first 104 patients from 41 sites in Germany (n=42), Sweden (n=31) and the United Kingdom (n=31) is consistent with results from the ESTEEM 1 and 2 clinical trials in patients with moderate to severe plaque psoriasis. Compared to the ESTEEM trials, patients treated with OTEZLA® in routine clinical practice had less severe skin involvement (Psoriasis Area and Severity Index [PASI]score mean 12.6 vs. 18.7 in ESTEEM 1)i,ii but suffered from a significantly impaired quality of life (Dermatology Life Quality Index [DLQI] mean 12.8 vs. 12.7 in ESTEEM 1)i,ii.  In APPRECIATE, 6±1 months following start of (OTEZLA®) treatment, data available from patient charts showed that 31/56 patients (55.4%) achieved PGA rating of 0 (clear) or 1 (almost clear)i and more than two-thirds (69.6%) of patients achieved a ≥5-point improvement on the DLQIi.   Furthermore, in the clinicians judgement, most patients treated with OTEZLA® showed a rapid (62.5%) and sustained (54.8%) response, and notably reduced plaque psoriasis (66.4%)i. Among patients with the following psoriasis locations and signs at treatment initiation, clinicians also reported improvements with scalp (47/71, 66.2%), nail (24/42, 57.1%), palmoplantar (18/26, 69.2%), as well as itch (49/67, 73.1%).i

The patient needs and benefit questionnaire aims to describe the most important treatment needs that patients expect to be improved by any therapy. Previously reported data from the APPRECIATE study included 102 patient questionnaires and revealed that key treatment needs (judged as “quite” / “very important”) include clearance of all skin lesions (93% of responders), to have confidence in healing (92%), to be free of itching (85%), to have fewer side effects (84%), to be able to lead a normal everyday life (83%), and to need less time for daily treatment (80%)ii.

After 6±1 months treatment, a majority of patients reported a benefit related to these key needs. Patients answered ‘moderately’, ‘quite’ or ‘very’ in the Patient Benefit Questionnaire (PBQ) in relation to clearance of skin lesions (60% of responders), confidence in healing (70%), being itch free (69%), to have fewer side effects (60%), to live a normal everyday life (72%) and spending less time for daily treatment (65%)ii.

“Albeit based on small numbers in this interim analysis, the APPRECIATE study provides important insights about the profiles and multiple needs of patients treated with OTEZLA® today in Europe. We are looking forward to learning more about how OTEZLA® can help address these needs in the full analysis of this ongoing study.” said Volker Koscielny MD, Head of Medical Affairs for the Celgene Inflammation & Immunology franchise in the EMEA Region.

Adverse events (AE) were reported in fifty patients (48.1%). Consistent with phase 3 studies, the most commonly reported AEs were diarrhoea (19.2%), nausea (16.3%), and headache (11.5%)i.  

About the APPRECIATE Study

APPRECIATE is a Multinational (6 country: Germany, The United Kingdom, Sweden, Switzerland, Ireland, Austria), Retrospective, Cross-Sectional Study of Real-World Experience of over 450 psoriasis patients treated with OTEZLA® in Clinical Dermatology Practice which aims to investigate patient characteristics, treatment outcomes, and benefits/limitations as perceived by patients and physicians.


This interim analysis reports on outcomes of clinical measures including PASI, DLQI and PGA, taken from patient medical records. It also includes impressions recorded by patients through the patient needs and benefit questionnaireiii.  Physician impressions were recorded through questionnaires that captured apremilast outcomes for each disease symptom at baseline and reasons for initiating apremilast, including experience in managing the patient on apremilast. These questionnaires were developed and agreed upon by expert consensus.


Full results from APPRECIATE are expected to be reported at an upcoming medical meeting.


About Psoriasis

Psoriasis is known to affect around 14 million people in Europe. It is a chronic and systemic inflammatory skin disorder, and is immune-mediated, meaning it is caused by an immune reaction in the body.


Psoriasis lesions can often be found on areas close to the joints such as the elbows and knees but can also appear on the scalp v. Nail psoriasis affects up to 50% of people with psoriasis and up to 90% of people living with psoriatic arthritis,. Up to 84% of people with psoriasis experience itching, and over a third of patients actually cite itch as the most important factor contributing to their disease.


75% of people living with psoriasis believe it has a negative impact on their quality of life and 83% of patients with psoriasis actively conceal the visible signs of their disease,.


About OTEZLA® (apremilast)

OTEZLA® (apremilast) is an oral inhibitor of (PDE4) specific for cyclic AMP (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. OTEZLA® has been launched in 27 countries globally, including 21 countries in the European Union. More than 221,000 patients worldwide – 53,000 in Europe alone – have been treated with OTEZLA® since approval.



Therapeutic indications

OTEZLA® is approved for the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).


OTEZLA®, alone or in combination with DMARDs, is also indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.



OTEZLA® is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients in the formulation.


OTEZLA® is contraindicated during pregnancy.


Warnings and precautions

Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.


The safety of OTEZLA® was not evaluated in psoriatic arthritis or psoriasis patients with moderate or severe renal impairment in the clinical studies. OTEZLA® should be dose reduced to 30 mg once daily in patients with severe renal impairment.


Weight decrease: The mean observed weight loss in patients treated for up to 52 weeks with OTEZLA® was 1.99 kg. A total of 14.3% of patients receiving OTEZLA® had observed weight loss between 5-10% while 5.7% of the patients receiving OTEZLA® had observed weight loss greater than 10%. None of these patients had overt clinical consequences resulting from weight loss. A total of 0.1% of patients treated with OTEZLA® discontinued due to adverse reaction of weight decreased. Patients who are underweight at the start of treatment should have their body weight monitored regularly. In the event of unexplained and clinically significant weight loss, these patients should be evaluated by a medical practitioner and discontinuation of treatment should be considered.


Pregnancy: Pregnancy should be excluded before treatment can be initiated. Women of childbearing potential should use an effective method of contraception to prevent pregnancy during treatment.


Psychiatric disorders: OTEZLA® is associated with an increased risk of psychiatric disorders such as insomnia and depression. Instances of suicidal ideation and behaviour, including suicide, have been observed in patients with or without history of depression (see section 4.8). The risks and benefits of starting or continuing treatment with OTEZLA® should be carefully assessed if patients report previous or existing psychiatric symptoms, or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended. Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation. If patients suffered from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt is identified, it is recommended to discontinue treatment with OTEZLA®.


Summary of the safety profile

The most commonly reported adverse reactions in Phase III clinical studies have been gastrointestinal (GI) disorders including diarrhoea (15.7%) and nausea (13.9%). These GI adverse reactions were mostly mild to moderate in severity, with 0.3% of diarrhoea and 0.3% of nausea reported as being severe. These adverse reactions generally occurred within the first 2 weeks of treatment and usually resolved within 4 weeks. The other most commonly reported adverse reactions included upper respiratory tract infections (8.4%), headache (7.9%), and tension headache (7.2%). Overall, most adverse reactions were considered to be mild or moderate in severity.


The most common adverse reactions leading to discontinuation during the first 16 weeks of treatment were diarrhoea (1.7%), and nausea (1.5%). The overall incidence of serious adverse reactions was low and did not indicate any specific system organ involvement. Hypersensitivity reactions were uncommonly observed in OTEZLA® clinical studies.


During the placebo-controlled period of the phase III clinical trials in psoriasis, 1.2% (14/1184) of patients treated with OTEZLA® reported depression compared to 0.5% (2/418) treated with placebo. None of these reports of depression was serious or led to study discontinuation.


Special populations

No overall differences were observed in the safety profile of elderly patients ≥ 65 years of age and younger adult patients < 65 years of age in the clinical studies.


The safety of OTEZLA® was not evaluated in psoriatic arthritis or psoriasis patients with hepatic impairment.


The safety and efficacy of OTEZLA® in children aged 0 to 17 years have not been established. There is no data available.


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Celgene International Sàrl, located in Boudry, in the Canton of Neuchâtel, Switzerland, is a wholly-owned subsidiary and International Headquarter of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.



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Kleyn CE et al. Psoriasis from Gene to Clinic. Presented at: Psoriasis from Gene to Clinic. November 30 – December 2, 2017; London UK.

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Editor's Details

Mike Wood

Last updated on: 30/11/2017

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